GAO: Few FDA-Ordered Postmarket, Postapproval Studies Are Completed

A lawmaker is taking the FDA to task after a Government Accountability Office report determined that more than 70 percent of postapproval studies ordered by the agency since January 2007 are ongoing.

The report, requested by Rep. Rosa DeLauro (D-Conn.), examines the types of devices for which the FDA had ordered postapproval or postmarket surveillance studies, as well as their status ― completed or ongoing. For ongoing studies, the GAO also examined whether adequate progress had been made or if the studies were delayed or inactive.

Putting Patients First

According to DeLauro, the GAO findings point out that medical devices are being put on the market without adequate evidence of their safety and effectiveness.

“People are not guinea pigs, and we should not be rushing devices to market,” she says in a prepared statement. “I will continue to monitor this situation closely to determine whether Congress should be taking action.”

According to the report, only 20 percent of postapproval studies ordered (62 of 313) had been completed, while another 8 percent were inactive. However, of the ongoing studies, 81 percent were progressing adequately, while the other 19 percent were delayed, as of February.

Although the report found that 88 percent of postmarket surveillance studies ordered were inactive (344 of 392), the GAO determined that 31 percent had been consolidated into another study. Another 31 percent had been terminated either because the manufacturer changed the indication or had demonstrated the objective of the study using publically available data. The remaining inactive studies didn’t fit in either category for a number of reasons, including the device is no longer on the market.

Most of the postapproval studies focused on cardiovascular devices, such as stents and heart valves. Researchers and others have raised questions about FDA’s oversight of the studies, including whether the agency ensures that they are completed, the GAO says.

Read the report here: www.fdanews.com/11-15-GAO-Report.pdf. — Jonathon Shacat